Quality Engineer Ii - Instrument Plant

BD / Waters Corporation

Sparks, MD, USA
Base: $75,800.00 - $121,300.00 usd annual; bonus/e...
Fully remote
Bachelor's degree in biological sciences or chemistry
2+ years experience in quality assurance or control
Fda 21 cfr 820 regulations knowledge
This role involves championing quality compliance across the entire product lifecycle while maintaining adherence to international and regional regulatory requirements

Job Summary

  • This role involves championing quality compliance across the entire product lifecycle while maintaining adherence to international and regional regulatory requirements.
  • The successful candidate will leverage sophisticated statistical tools and Six Sigma methodologies to drive continuous improvement and resolve complex non-conformance issues.
  • Waters Corporation, a global leader in life sciences, offers a culture of relentless innovation where employees collaborate to turn scientific challenges into breakthroughs that improve lives worldwide.

Matching Summary

This role involves championing quality compliance across the entire product lifecycle while maintaining adherence to international and regional regulatory requirements.

Salary

Base: $75,800.00 - $121,300.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture

Skills & Requirements

Must-have

  • Bachelor's degree in Biological Sciences or Chemistry
  • 2+ years experience in Quality Assurance or Control
  • FDA 21 CFR 820 regulations knowledge
  • ISO 9000:2000 and ISO 13485:2003 standards knowledge
  • SAP transaction experience
  • Six Sigma tools and statistical analysis proficiency
  • Root cause analysis and FMEA expertise

Nice-to-have

  • First-hand audit experience preferred
  • Microbiology or molecular science background
  • Manual assembly manufacturing experience
  • Medical device validation experience
  • Data efficiency optimization skills

Key Requirements

  • Bachelor's degree required
  • Minimum 2 years QA/QC experience
  • Experience in medical device manufacturing facility
  • Knowledge of FDA 21 CFR 820 regulations
  • Proficiency with SAP and statistical software

Work Rights

Not specified

Tailored Resume

Cover Letter